A Phase 4 interventional study of a scalp block in Pain, sponsored by Chiang Mai University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-27.
Sponsored by Chiang Mai University · Phase 4, Interventional, and Prevention
It is a randomized control trial to compare the surgical plethysmographic index (SPI) response during a Mayfield head-holder insertion in neurosurgical patients who receive a scalp block versus those who do not receive the scalp block after induction of anesthesia with propofol with fentanyl and intubation with cis-atracurium.
Study design is a randomized controlled trial Participants include adult neurosurgical patients scheduled to have a Mayfield head-holder insertion for supratentorial craniotomy Intervention is a scalp block prior to a Mayfield head holder insertion. Comparison is 'no scalp block' Outcome is surgical plethysmographic index (SPI) responses during/after a Mayfield head holder insertion Sample size includes 30 cases (15 cases per arm)
The eligible neurosurgical patients will be randomly allocated, by a concealed randomization process, to receive or not to receive a scalp block after induction and intubation with propofol/fentanyl and cisatracurium. Surgical plethysmographic index, direct arterial blood pressure, heart rate (EEG), End tidal Carbondioxide, Bispectral/entropy (40-60) will be recorded every one minute before/after induction and intubation, before/after the scalp block, and before/after the Mayfield head-holder insertion. The Mayfield head-holder insertion will be performed by a neurosurgeon who will be blinded to the allocated groups.
Data analysis is performed to compare the change of SPI during and after the Mayfield head-holder insertion from the baseline in both groups by using repeated measure ANOVA at the significant level of 0.05.
Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A standard scalp block ,with 0.5% bupivacaine total dose \< 3 mg/kg, is performed by an anesthesiologist.
Procedure: a scalp block
An anesthesiology will pretend to perform the scalp block,
Bilateral blocks of six nerves: ie. supraorbital and supraorbital nerves (V1), zygomaticotemporal nerves (V2) , auriculotemporal nerves , greater occipital nerves, and lesser occipital nerves will be performed by a well trained anesthesiologist with 0.5% bupivacaine not exceeding 3 mg/kg
the change of SPI from baseline
Time frame: 30 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chiang Mai University